AccessGUDID - DEVICE: plasmatherm (04059201000018)

GUDID

Device Identifier (DI) Information

Brand Name: plasmatherm
Version or Model: US-TCP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00000460
Company Name: Barkey GmbH & Co. KG

Primary DI Number: 04059201000018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312555782 *Terms of Use

Device Description: Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43434	Cryopreserved blood/tissue thawing unit	An electrically-powered device intended to be used to thaw, in a controlled manner, frozen units of whole blood, blood components (e.g., blood cells, plasma), and/or other biological tissues contained in storage cryobags. The device is typically programmable and can use a number of heating methods to achieve thawing (e.g., dry heat, microwave oven, water bath); it may provide agitation and be able to detect when thawing has been completed.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZL	Device, Warming. Blood And Plasma

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK100063	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fbeaffaf-f488-4a5b-8c4a-61487cc1b8de
Public Version Date: July 19, 2021
Public Version Number: 5
DI Record Publish Date: October 13, 2016